Label: ALUMINUM HYDROXIDE liquid

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 2, 2023

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  • Active ingredient (in each 5 mL teaspoonful)

    Aluminum hydroxide 320 mg

  • Purpose

    Antacid

  • Uses

    relieves

    • heartburn
    • acid indigestion
    • sour stomach

  • Warnings

    Ask a doctor or pharmacist before use if you are taking a prescription drug.

    Antacids may interact with certain prescription drugs.
    When using this product you may get constipated

    Stop use and ask a doctor if symptoms last more than 2 weeks

    Keep out of reach of children.

  • Directions

    • shake well before using
    • do not take more than 12 teaspoonfuls in 24 hours
    • do not use the maximum dosage for more than 2 weeks
    • dosage: 2 teaspoonfuls 5-6 times daily after meals and at bedtime followed by a sip of water if needed
  • Other information

    • store at room temperature
    • protect from freezing
    • keep tightly closed
    • TAMPER-EVIDENT: DO NOT USE IF FOIL SEAL UNDER CAP IS BROKEN OR MISSING.
  • Inactive ingredients

    benzyl alcohol, butylparaben, flavor, glycerin, hydroxyethylcellulose, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol solution

    Questions or comments?

    1-800-645-2158

  • package Label

    compare to the active ingredient in AMPHOJEL

    Rugby

    NDC 0536-0091-85
    MINT FLAVOR

    Aluminum Hydroxide Gel, USP

    ANTACID
    SUGAR FREE
    This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.
    Rugby Laboratories, INC. is not affiliated with the owner of the trademark Amphojel.
    16 fl oz (473 mL)

    rug al

  • INGREDIENTS AND APPEARANCE
    ALUMINUM HYDROXIDE 
    aluminum hydroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-0091
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE320 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-0091-85473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00102/01/2005
    Labeler - Rugby Laboratories (079246066)
    Registrant - GCP Laboratories (965480861)
    Establishment
    NameAddressID/FEIBusiness Operations
    GCP Laboratories965480861manufacture(0536-0091)
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